Using an unsubstituted quatenary ammonium salt composition with other ingredients as a skin sanitizing solution and natural skin conditioner

ABSTRACT

A water based, alcohol-free, skin sanitizing solution with a natural skin softener, where the nature of the biocidal enhancer used in the process of making the solution significantly increases efficacy while simultaneously enabling much more economical manufacturing, processing and transportation of the product. Because it is water based, no further moisturizing additives are required, and those with sensitive skin, diabetes, allergies or religious beliefs are able to use the product without concern.

FIELD OF THE INVENTION

The invention relates to an unsubstituted quaternary ammonium salt thatis an effective biocide in combination with a germicidal/bactericidalingredient, alkyl-dimethyl-benzyl-ammonium chloride (BenzalkroniumChloride or BAC) and Carbamide peroxide (CH₆N₂O₃).

The invention describes a desirable effect of the chemistry combinationwhere the creation of Hydronium Ions are known to mediate chemicalreactions by attaching themselves to the hydrophilic ends of molecules,specifically sites with partial negative charges or rich in electrondensity. The formation of an adduct, for steric hindrance where addingCarbamide to the existing molecular chain will form a lightly bondedbi-molecule chain making the quaternary ammonia salt larger and moredifficult to penetrate the skin flora while maintaining its germicidalfunctionality.

The described unsubstituted quaternary ammonium salt composition withother ingredients has been shown to be effective in testing againstE-coli, Salmonella, Pseudomonas, Listeria, H1N1, NDM1, c-DifficileSpores, Rhinovirus, MRSA and a wide range of other bacteria and viruses,molds and spores.

Other additives such as scents, humectants, antifungal,anti-inflammatory, cicatrizants and hemostatic agents can be added tothe chemistry combination to promote healing as well as other medicinalbenefits.

BACKGROUND OF THE INVENTION

Hand sanitizers have been marketed and sold for decades. However, nearlyall sanitizers use alcohol at a minimum of 62% concentration as both anantiseptic and a drying agent. According to Center for Disease Control(CDC) recommendations, a hand sanitizer should contain at least 60%alcohol by volume in order to be effective. Alcohol is harsh on theskin, and also is not recommended for use by people with diabetes as itcan dramatically affect blood glucose readings. Certain religiousbeliefs restrict the use of alcohol on the hands and providing anon-alcohol based hand sanitizer with effective killing rates address sproblem for a large community.

Alcohol-free hand sanitizers are available, but their effectiveness islimited by the number of active ingredients allowed under the FDA 1974Tentative Final Monograph. Thus, it is necessary to find an ingredient,or combination of ingredients, that can significantly enhance theallowed biocides from the Monograph.

The FDA requirement for hand sanitizers must include active ingredientfrom a list identified in the FDA 1978 Monograph. One specific biocidelisted in the Monograph is Benzalkronium Chloride (BAC) that acts as asanitizer to disrupt the cellular membrane of micro-organisms. Thebiocide activity of BAC is enhanced by the action of the long chainsubstitutes, acting as solvents of the lipid (or other soluble) parts ofthe cellular membrane. This event disrupts the integrity of the cellularmembrane causing the outflow of the intracellular liquid. The additionof a mineral acid as H₂So₄ lowers the pH of the system, leading to theformation of Hydronium ions.

Hydronium ions are known to mediate chemical reactions by attachingthemselves to the hydrophilic ends of molecules, specifically sites withpartial negative charges or rich in electron density. H+ will bonddisrupting the general characteristics of the lipid while the long chainof BAC will solvate the hydrocarbon chain.

In addition, the solution may contain other ingredients not listed asactive by the FDA and may include but not limited to naturalmoisturizers such as Carbamide. The described unsubstituted quaternaryammonium salt composition is compatible with different aromas andfragrances, such as Rose Water, Witch Hazel, Lavender, Lilac and is notlimited by one or more volatilized chemical compounds that can be addedto the solution at a very low concentration that stimulates the humanolfactory senses.

Carbamide is also highly water-soluble due to its ability to formmultiple hydrogen bonds with the low pH hydronium ions in the chemistrycomposition. The natural conditioning properties of Carbamide, alsocalled urea peroxide, urea hydrogen peroxide (UHP), and percarbamide, isan adduct of hydrogen peroxide and urea and is similar to hydrogenperoxide as an oxidizer. Carbamide has several other applications. Inveterinary medicine, for instance, it is used as a topical antisepticand a diuretic.

Carbamide appears as a white crystalline solid which dissolves in waterto give free hydrogen peroxide and is readily available with thesolubility of commercial samples varying from 0.05 g/ml to more than 0.6g/ml. The chemical formula is CH₆N₂O₃. As a natural skin conditioner theallergic reactions by users to dyes and chemicals found in readilyavailable alcohol based hand sanitizers is avoided. The use of low dosesof Carbamide has shown to reduce the effects of acme and psoriasis onthe skin without damaging side effects found in some medications.

As documented in Wikipedia website, Aloe vera is now widely used onfacial tissues, where it is promoted as a moisturizer and/oranti-irritant to reduce chafing of the nose of users suffering hay-feveror cold. Aloe vera is also used for soothing the skin, and keeping theskin moist to help avoid flaky scalp and skin in harsh and dry weather.Aloe vera may also be used as a moisturizer for oily skin. Aloe vera canbe easily added to the described highly protonated, low pH,nondermathropic solution as a moisturizer.

Taspine is an alkaloid extracted from trees of Croton (familyEuphorbiaceae) of the western Amazon region that has been used bynatives and others as a vulnerary agent when purified from the tree sap.Some testing and data suggest that taspine promotes early phases ofwound healing in a dose-dependent manner with no substantialmodification thereafter. Its mechanism of action is probably related toits chemotactic properties on fibroblasts and is not mediated by changesin extracellular matrix. Additionally, Taspine can be added to thedescribed highly protonated, low pH, nondermathropic solution as anatural moisturizer and wound healing ingredient.

SUMMARY OF THE INVENTION

The described invention of using a base chemistry where a highconcentration of Hydronium Ions is created as a base chemistry whereother ingredients described in the invention forms a composition thatboth reduces bacteria on the skin and a natural moisturizer withextended protection up to forty-eight hours after application to theskin.

As a result, the described skin sanitizing solution both sanitizes andmoisturizes the skin on contact without the addition of harsh chemicals,such as alcohol, and without the need for skin conditioning additivesthat may contain objectionable chemistry, dyes and perfumes.

DETAILED DESCRIPTION OF THE INVENTION

The invention is an unsubstituted quaternary ammonium salt compositionwith other ingredients that comprises a composition that isnon-flammable, alcohol-free, non-stinging, highly protonated, andnondermatropic. The composition has a very high Hydronium proton countand is created by a process involving the blending of a premix thatcomprises a highly protonated, non-corrosive, nondermatropic Hydroniumcarrier and a biocide, added to a predetermined quantity of water untilit dissolves. The biocide comprises one or more quaternary ammoniumcompounds.

The described unsubstituted quaternary ammonium salt composition withother ingredients comprises a blend of an inorganic acid, a sulfate, andwater or a blend of organic acid, a sulfate, and water. The quaternaryammonium compound is selected from one or more of the group consistingof Benzalkonium Chloride, Cetylpyridinium Chloride, Silver Chlorideadsorbed to titanium dioxide (initially notified under silver chloride),Cetalkonium chloride, Benzyldimethyl (octadecyl) ammonium chloride,Miristalkonium chloride, Dimethyldioctylammonium chloride, Hydrogenchloride/hydrocholoric acid, Silver Chloride, Dodecylguanidinemonohydrochloride, Bromine chloride,Dimethyloctadecyl[3-(trimethoxysilyl) propyl]ammonium chloride,Decyldimethyloctylammonium chloride, Benzyldimethyloleylammoniumchloride, Dimethyltetradecyl[3-(trimethoxysilyl)propyl]ammoniumchloride, benzylcoco alkyldimethyl chlorides, dicocoalkyl dimethyl,chlorides, bis(hydrogenated tallow alkyl)dimethyl chlorides,benzyl-c8-18-alkyldimethyl chlorides, benzyl-c12-18-alkyldimethylchlorides, di-C6-12-alkyldimethyl chlorides, benzyl-c8-16-alkyldimethylchlorides, di-c8-10-alkyldimethyl chlorides, benzyl-C10-16-alkyldimethylchlorides, Octenidine dihydrochloride di-C8-18 alkyldimethyl, chlorides,benzyl-C12-14-alkyldimethyl chlorides,C12-14-alkyl[(ethylphenyl)methyl]dimethyl chlorides.

The inorganic acid is selected from one or more of the group consistingof Sulfuric acid, Hydrochloric acid, Nitric acid, Phosphoric acid, Boricacid, Hydrofluoric acid, Hydrobromic acid.

The organic acid selected from one or more of the group consisting ofLactic acid, Acetic acid, Formic acid, Citric acid, Oxalic acid, Uricacid.

The solution may further comprise a skin permeation enhancer orconditioner selected from one or more of the group consisting of naturalcomponents and vitamins, minerals, urea or anti-oxidants to enhance thecomposition's natural skin moisturizing and protection against thespread of acme and psoriasis.

A thickener may be added to make a gel formula solution. The thickeneris selected from one or more of the group consisting of Xanthan gum,Alginic acid, Sodium alginate, Ammonium alginate, Calcium alginate,Propylene glycol alginate, Propane-1,2-diol alginate, Agar, Carrageenan,Processed euchuema seaweed, Furcelleran, Aribinogalactan larch gum,Locust Bean (carob gum), Oat gum, Guar gum, Tragacanth, Acadia Gum (GumArabic), Karaya gum, Tara Gum, Gellan gum, Sorbitol, Mannitol, Glycerol,Konjac, Konjac gum, Polyoxethylene (8) sterate, Polyoxyl 8 stearate,Polyoxyethylene (40) stearate, Polyoxyethylene (20) sorbitan monolaurate(polysorbate 20), Polysorbate 80, Polyoxethylene sorbitan mono-oleate,Polyoxethylene sorbitan monopalminate, Polysorbate 40, Tween 40,Polyxethylene sorbitan monostearate, Polysorbate 60, Tween 60,Polyoxyethylene-20-sorbitan tristearate, Polysorbate 65, Tween 65,Pectin, Amidated pectin, Gelatine, Ammonium phosphatides, Sucroseacetate isobutyrate, SAIB, Sucrose diacetate hexaisobutyrate, Glycerolesters of wood rosins, Sodium and potassium pyrophosphates,Diphosphates, Ammonium phosphate (diabasic and monobasic), Sodium andpotassium triphosphate, Triphosphate, Sodium and potassiumpolyphosphates, Polyphosphates, Beta-cyclodextrine, Cellulose(microcrystalline and powdered), Methyl cellulose, Ethyl cellulose,Hydroxypropyl cellulose, Hydroxypropyl methyl cellulose,Methylethylcellulose, Carboxymethyl cellulose, Sodium carboxymethylcellulose, Crosslinked sodium carboxymethyl cellulose, Sodium caseinate,Magnesium stearate, Sodium, potassium and calcium salts of fatty acids,Magnesium salts of fatty acids, Mono- and diglycerides of fatty acids(glyceryl monostearate, glyceryl distearate), Acetic and fatty acidesters of glycerol, Acetic acid esters of mono- and diglycerides offatty acids, Lactic and fatty acid esters of glycerol, Lactic acidesters of mono- and diglycerides of fatty acids, Citric and fatty acidesters of glycerol, Citric acid esters of mono- and diglycerides offatty acids, Tartaric and fatty acid esters of glycerol, Tartaric acidesters of mono- and diglycerides of fatty acids, Diacetyltartaric andfatty acid esters of glycerol, mon- and diacetyl tartaric acid esters ofmonoand diglycerides of fatty acids, Mixed acetic and tartaric acidesters of mono- and diglycerides of fatty acids, Sucrose esters of fattyacids, Sucroglycerides, Polyglycerol esters of fatty acids, Polyglycerolesters of interesterified ricinoliec acid, Propylene glycol mono- anddi-esters, Propane 1,2-Diol esters of fatty acids, Lactylated fatty acidesters of glycerol and propane-1,2-diol, Thermally oxidized soy bean oilinteracted with mono- and diglycerides of fatty acids, Dioctyl sodiumsulphosuccinate, Sodium oleyl or stearoyl lactylatestearoyl-2-lactylate, Calcium stearoyl-2-lactylate, Stearyl tartrate,sorbitan monostearate, Sorbitan tristearate, Span 65, Sorbitanmonolaurate, Span 20, Sorbitan mono-oleate, Span 80, Sorbitanmonopalmitate, Span 40.

The unsubstituted quaternary ammonium salt created by the invention wastested by an independent laboratory and the results recorded for eachmicrobe studied. It is important to note that alcohol based handsanitizers with or without the active ingredient BZK does not offer thesame results against MRSA, c-Diff spores, H1N1.

Average Untreated Number Percent Microbe Control Recovered ReductionMRSA (30 Seconds) 1.7 × 10⁵ 3.3 × 10⁰ 99.998% MRSA (180 seconds) 1.7 ×10⁵ <1.0 × 10⁰  99.999% c-Diff Spores Trial 1 3.3 × 10³  <1.00 99.97%Trial 2 3.3 × 10³  <1.00 99.97% Trial 3 3.3 × 10³  <1.00 99.97% Trial 43.3 × 10³  <1.00 99.97% Trial 5 3.3 × 10³  <1.00 99.97% NDM-1 Trial 19.6 × 10⁵ <5.0 99.9995% Trial 2 9.6 × 10⁵ <5.0 99.9995% Trial 3 9.6 ×10⁵ <5.0 99.9995% Trial 4 9.6 × 10⁵ <5.0 99.9995% Trial 5 9.6 × 10⁵ <5.099.9995% Rhinovirus 39 6.7 × 10⁵ 4.8 × 10⁰ 99.993% Influenza A 3.1 × 10⁴<2.2 99.993% (H1N1) PRD-1 2.0 × 10⁴ 4.3 × 10⁰ 99.98% Bacteriophage E.Coli 9.10 × 10⁵  <0.5 99.9999% E. Coli (Dry Test) 5.6 × 10⁴ 3.7 × 10²99.3% Salmonella 1.1 × 10⁶ <0.5 99.9999% Enterica Salmonella (Dry Test)1.6 × 10⁵ 1.6 × 10² 99.9% Enterica

This product is manufactured according to FDA Tentative Final Monograph(1974, 1978, 1991, 1994, 2002). All testing is performed by anindependent registered laboratory, according to test methods describedin AOAC Official Method 961.02 (Germicidal Spray Products asDisinfectants), ASTME 1053-97 (Standard Test Method for Efficacy ofVirucidal Agents Intended for Inanimate Surfaces), and from ASTME2111-00 (Standard Quantitative Carrier Test Method to Evaluate theBactericidal, Fungicidal, Mycobactericidal and Sporicidal Potencies ofLiquid Chemical Germicides). The FDA does not specify testing protocolsfor this product. Copies of full reports are available upon request.

The solution also was graded minimally irritating at 2.8 (non-irritant)on the standardized Draize Test scale where 0 is non-irritating and 110is severe/extreme where skin damage will occur.

According to Wikipedia website, the Draize Test is an acute toxicitytest devised in 1944 by the Food and Drug administration (FDA)toxologists John H. Draize and Jacob M. Spines. Initially used fortesting cosmetics, the procedure involves applying 0.5 mL or 0.5 g of atest substance to the eye or skin of a restrained, conscious animal, andthen leaving it for set amount of time before rinsing it out andrecording its effects. The animals are observed for up to 14 days forsigns of erythema and edema in the skin test, and redness, swelling,discharge, ulceration, hemorrhaging, cloudiness, or blindness in thetested eye. The test subject is commonly an albino rabbit, though otherspecies are used too, including dogs. The animals are euthanized aftertesting if the test renders irreversible damage to the eye or skin.Animals may be reused for testing purposes if the product tested causesno permanent damage. Animals are typically reused after a “wash out”period during which all traces of the tested product are allowed todisperse from the test site. The FDA supports the test, stating that “todate, no single test, or battery of tests, has been accepted by thescientific community as a replacement [for] . . . the Draize test”

PREFERRED EMBODIMENT

One embodiment of the invention consists of the use of the describedunsubstituted quaternary ammonium salt composition with otheringredients which are fully incorporated herein by reference, as theIonic Carrier premix. In this embodiment, 10 grams of the describedhighly protonated, low pH, nondermathropic solution are blended in a1:2ratio with water, by weight. This blend is then added to 5.5 grams ofBenzalkonium Chloride, mixed with 3 grams of Urea, and 481.5 grams ofwater.

The amount of thickener can vary, depending upon the final intended use.0.5% to 1% xanthan gum gives a good consistency for a hand gel. Theformula is a composition, which is a highly protonated, supercharged,non-corrosive liquid proton suspending composition.

The manufacturing process to create the described unsubstitutedquaternary ammonium salt with is well known and beginning as early asthe 1980's various chemists and inventors have experimented with thenature of this reaction of adding acid to the water. Generally speaking,these reactions and resulting compounds have lacked stability and themanufacturing process was extremely expensive for commercialization.

However, this invention has created a compound reaction of the severalelements for making the described unsubstituted quaternary ammonium saltcomposition with other ingredients of adding sulfuric acid of at least88% purity in a controlled manner to water while vigorously stirring andagitating said solution to control the temperature of the exothermicreaction.

It should be understood that the preceding is merely a detaileddescription of one or more embodiments of this invention and thatnumerous changes to the disclosed embodiments can be made in accordancewith the disclosure herein without departing from the spirit and scopeof the invention. The preceding description, therefore, is not meant tolimit the scope of the invention. Rather, the scope of the invention isto be determined only by the appended claims and their equivalents.

What is claimed is:
 1. A skin sanitizing solution comprising hydroniumhaving a proton count between 4×10²⁰ and 5.8×10²³ and an unsubstitutedquaternary ammonium salt composition.
 2. The solution according to claim1, further comprising a blend of an inorganic acid and water.
 3. Thesolution according to claim 1, further comprising a blend of an organicacid and water.
 4. The solution according to claim 1, wherein thequaternary ammonium salt composition is selected from the groupconsisting of Benzalkonium Chloride, Cetylpyridinium Chloride, SilverChloride Adsorbed to titanium dioxide (initially notified under silverchloride), Cetalkonium chloride, Benzyldimethyl (octadecyl) ammoniumchloride, Miristalkonium chloride, Dimethyldioctylammonium chloride,Hydrogen chloride/hydrocholoric acid, Silver Chloride, Dodecylguanidinemonohydrochloride, Bromine chloride,Dimethyloctadecyl[3-(trimethoxysilyl) propyl]ammonium chloride,Decyldimethyloctylammonium chloride, enzyldimethyloleylammoniumchloride, Dimethyltetradecyl[3-(trimethoxysilyl) propyl]ammoniumchloride, benzylcoco alkyldimethyl chlorides, dicocoalkyl dimethyl,chlorides, bis(hydrogenated tallow alkyl)dimethyl, chlorides,benzyl-c8-18-alkyldimethyl, chlorides, benzyl-c12-18-alkyldimethyl,chlorides, di-C6-12-alkyldimethyl, chlorides,benzyl-c8-16-alkyldimethyl, chlorides, di-c8-10-alkyldimethyl,chlorides, benzyl-C10-16-alkyldimethyl, chlorides, Octenidinedihydrochloride, di-C8-18-alkyldimethyl, chlorides,benzyl-C12-14-alkyldimethyl, chlorides,C12-14-alkyl[(ethylphenyl)methyl]dimethyl, chlorides, and combinationsthereof.
 5. The solution according to claim 2, wherein the inorganicacid is selected from the group consisting of Sulfuric acid,Hydrochloric acid, Nitric acid, Phosphoric acid, Boric acid,Hydrofluoric acid, Hydrobromic acid, and combinations thereof.
 6. Thesolution according to claim 3, wherein the organic acid is selected fromthe group consisting of Lactic acid, Acetic acid, Formic acid, Citricacid, Oxalic acid, Uric acid, and combinations thereof.
 7. The solutionaccording to claim 1, further comprising a skin permeation enhancer ormoisturizer selected from the group consisting of Vitamins, minerals,urea, taspine, anti-oxidants, and combinations thereof to enhance thecomposition's natural skin moisturizing, protection and conditioningabilities.
 8. The solution according to claim 1, further comprising athickener configured to make a gel formula of the solution.
 9. Thesolution according to claim 8, wherein the thickener is selected fromthe group consisting of Xanthan gum, Alginic acid, Sodium alginate,Ammonium alginate, Calcium alginate, Propylene glycol alginate,Propane-1,2-diol alginate, Agar, Carrageenan, Processed euchuemaseaweed, Furcelleran, Aribinogalactan larch gum, Locust Bean (carobgum), Oat gum, Guar gum, Tragacanth, Acadia Gum (Gum Arabic), Karayagum, Tara Gum, Gellan gum, Sorbitol, Mannitol, Glycerol, Konjac, Konjacgum, Polyoxethylene (8) sterate, Polyoxyl 8 stearate, Polyoxyethylene(40) stearate, Polyoxyethylene (20) sorbitan monolaurate (polysorbate20), Polysorbate 80, Polyoxethylene sorbitan mono-oleate, Polyoxethylenesorbitan monopalminate, Polysorbate 40, Tween 40, Polyxethylene sorbitanmonostearate, Polysorbate 60, Tween 60, Polyoxyethylene-20-sorbitantristearate, Polysorbate 65, Tween 65, Pectin, Amidated pectin,Gelatine, Ammonium phosphatides, Sucrose acetate isobutyrate, SAIB,Sucrose diacetate hexaisobutyrate, Glycerol esters of wood rosins,Sodium and potassium pyrophosphates, Diphosphates, Ammonium phosphate(diabasic and monobasic), Sodium and potassium triphosphate,Triphosphate, Sodium and potassium polyphosphates, Polyphosphates,Beta-cyclodextrine, Cellulose (microcrystalline and powdered), Methylcellulose, Ethyl cellulose, Hydroxypropyl cellulose, Hydroxypropylmethyl cellulose, Methylethylcellulose, Carboxymethyl cellulose, Sodiumcarboxymethyl cellulose, Crosslinked sodium carboxymethyl cellulose,Sodium caseinate, Magnesium stearate, Sodium, potassium and calciumsalts of fatty acids, Magnesium salts of fatty acids, Mono- anddiglycerides of fatty acids (glyceryl monostearate, glyceryldistearate), Acetic and fatty acid esters of glycerol, Acetic acidesters of mono- and diglycerides of fatty acids, Lactic and fatty acidesters of glycerol, Lactic acid esters of mono- and diglycerides offatty acids, Citric and fatty acid esters of glycerol, Citric acidesters of mono- and diglycerides of fatty acids, Tartaric and fatty acidesters of glycerol, Tartaric acid esters of mono- and diglycerides offatty acids, Diacetyltartaric and fatty acid esters of glycerol, mon-and diacetyl tartaric acid esters of mono- and diglycerides of fattyacids, Mixed acetic and tartaric acid esters of mono- and diglyceridesof fatty acids, Sucrose esters of fatty acids, Sucroglycerides,Polyglycerol esters of fatty acids, Polyglycerol esters ofinteresterified ricinoliec acid, Propylene glycol mono- and di-esters,Propane 1,2-Diol esters of fatty acids, Lactylated fatty acid esters ofglycerol and propane-1,2-diol, Thermally oxidized soy bean oilinteracted with mono- and diglycerides of fatty acids, Dioctyl sodiumsulphosuccinate, Sodium oleyl or stearoyl lactylatestearoyl-2-lactylate, Calcium stearoyl-2-lactylate, Stearyl tartrate,sorbitan monostearate, Sorbitan tristearate, Span 65, Sorbitanmonolaurate, Span 20, Sorbitan mono-oleate, Span 80, Sorbitanmonopalmitate, Span 40, and combinations thereof.